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Terminated Phase 3 Interventional Results available

Tecfidera Slow-Titration Study

ClinicalTrials.gov ID: NCT02428231

Public ClinicalTrials.gov record NCT02428231. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 7:42 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients With Multiple Sclerosis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary objective of the study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the incidence of dimethyl fumarate (DMF \[Tecfidera\])-related gastrointestinal (GI) adverse events (AEs) in participants with multiple sclerosis (MS). The secondary objective of this study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the average severity and duration of GI symptoms over 12 weeks of DMF treatment in this study population.

Study identification

NCT ID
NCT02428231
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Biogen
Industry
Enrollment
62 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 2015 (Type not available)
Primary completion
Dec 2015 (Actual)
Completion
Jan 2016 (Actual)
Last update posted
May 5, 2017

2015 – 2016

United States locations

U.S. sites
15
U.S. states
10
U.S. cities
15
Facility City State ZIP Site status
Research Site Gilbert Arizona — —
Research Site Phoenix Arizona — —
Research Site Long Beach California — —
Research Site Miami Florida — —
Research Site Avon Indiana — —
Research Site Franklin Indiana — —
Research Site Overland Park Kansas — —
Research Site Lewiston Maine — —
Research Site Asheville North Carolina — —
Research Site Cary North Carolina — —
Research Site Charlotte North Carolina — —
Research Site Wilmington North Carolina — —
Research Site Cincinnati Ohio — —
Research Site Dallas Texas — —
Research Site Wenatchee Washington — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02428231, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 5, 2017 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02428231 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →